# K262121: Ion-L Navigated Instruments

- Pathway: 510(k) (Special)
- Applicant: SurGenTec, LLC
- Decided: Jul 24, 2026 after 31 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K003155 (2001). 357 ancestors in all.
No later device cites it as a predicate yet.
4 of 358 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260329: Ion-C Navigation Instruments, SurGenTec, LLC (2026) Summary page 5.

## Indications for use
The Ion-L Navigated Instruments are intended to be used with the Ion-L System Facet Implants during spinal surgery to assist the surgeon in precisely locating anatomical structures, specifically the lumbar facet joint, in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation System S8, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. Fluoroscopy must be used to confirm final implant placement.

Source page: https://510kreport.com/device/K262121
Methodology: https://510kreport.com/methodology